DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Response to Amendments Applicant argues that not all PI3K inhibitors treat pancreatic cancer and this is shown because the prior art teaches screening them. If they all worked, they would not need to be screened. The examiner agrees that not all work. The standard for establishing a prima facie showing of obviousness is that there is a reasonable expectation of success. If there was not a reasonable expectation of success that they would work, they would similarly not be screened for efficacy. Applicant argues that Conway teaches treating pancreatic cancer, but also cancers generally. The examiner notes that PDAC is taught to account for 95% of pancreatic cancers and Conway explains: “ Collectively, this suggests that application of PI3K pathway inhibitors as a PDAC therapy may provide an opportunity for dual targeting of cancer cells and the deregulated cancer-associated stromal components. ” Id This provides specificity with respect to pancreatic cancer to establish a prima facie showing. Applicant further argues that Conway refers to toxicity and tolerability of PIK3 inhibitors. The examiner notes that many cancer treatments have some degree of adverse events and the dosage of an effective treatment can be optimized and titrated as necessary. The totality of the prior art as a whole provides a reasonable expectation of success in administering a PI3K inhibitor to treat pancreatic cancer. The PI3K pathway is a known target for treating pancreatic cancers. The examiner notes that while not “automatically” assumed to treat cancers, there is a reasonable and predictable expectation of success in doing so. Applicant argues that the claimed PI3K δ compound is more efficacious than other PI3K inhibitors. Further, Applicant argues that unexpected effects are demonstrated. Examples 1 and 3 show that the claimed agent is very tolerable. Further, it has a surprisingly good safety profile with respect to ALT and AST enzyme elevation. The examiner notes that unexpected results require a showing that compares the compounds of the closest prior art to that claimed. Example 1 provides a comparison to a control. Example 1 also provides a comparison of a combination. For a showing for a combination to be commensurate in scope with the claims, the claims would also need to be limited to that specific combination. Thus, this would not apply even if proper to claim 1. Further, Applicant argues that the safety profile of the compound of Formula (I) is argued to be unexpected. If this is the case, Applicant can show a statistically significant advantage of the claimed compound in treating pancreatic cancer as compared to the class of compounds taught by Gaillard that share a substantial overlap in chemical structure. If, e.g., Applicant can show such distinction of compound 339 compared to many others in such method , such showing may be sufficient to overcome the cited prior art. However, it is not clear from the record that some or even many of those similarly structured compounds do not also possess a similar safety profile to the instantly claimed compound. Further, Gaillard indicates that some PI3K inhibitors can be used to potentiate the effects of other anticancer agents. So, data that would show unexpected efficacy would compare the claimed compounds efficacy and adverse event/toxicity profile to the efficacy and adverse event/toxicity profile of a representative class of similarly structure compounds taught by Gaillard. As such, a prima facie showing is established because the efficacy of the claimed compound in treating pancreatic cancer in view of the prior art as a whole is reasonable and a comparison to show the unexpected nature of the claimed compound compared to other similarly structured PI3K inhibitors taught by the closest prior art has not been established. Status of the Claims Claims 1-12 are pending and examined. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Clai ms 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkie et al. , (US2016/0128311), in view of Tomasini et al. , (US2020/0088732) (filed April 12, 2018), in view of Gaillard et al., (WO2011/058149) (cited in IDS), in view of Conway et al. , “ Combating pancreatic cancer with PI3K pathway inhibitors in the era of personali z ed medicine ,” JRW et al. Gut 2019;68:742-758, in view of Stockley et al. , (U.S. Pat. No. 10,654,846). Wilkie teaches methods for screening and treating pancreatic ductal adenocarcinoma (PDA) by administering taxanes, gemcitabine, and an Axl kinase inhibitor. See Abstract. Administration can be oral among many other acceptable routes of administration. See par. 11. The taxane that can be administered to treat PDA includes nab-paclitaxel in combination with gemcitabine for oral administration. See prior art claims 1, 11, 13, and 14. Pharmaceutically acceptable carriers and excipients can be used. Se par. 155. A preferred carrier for oral administration is a diluent. See par. 162. In some embodiments exemplary candidate drugs include inhibitors of PI3k, which can be administered with gemcitabine and/or paclitaxel. See par. 203. Wilkie does not teach anti-PD-1 or anti-PD-L1 therapy. Tomasini teaches treating PDA by administering gemcitabine and nab-paclitaxel. See par. 2. Additionally, treatment can also include inhibitors of PD-1 , such as a PD-L1 ligand. See prior art claim 14. Administration can be oral or most other routes of administration. See par. 124, e.g. Wilkie does not teach the claimed PI3K inhibitor (i.e., the compound of Formula (I)). Gaillard teaches compounds that are PI3K inhibitors and they include compound 339 on page 69, which is shown below and is the claimed compound in claim 1. The compounds are PI3K inhibitors for treating conditions including cancer. See Abstract, p1 and prior art claim 8, e.g. Compositions can be administered orally. See p116, e.g. Gaillard does not teach PI3K inhibitors for treating PDAC. Conway teaches PDAC accounts for about 95% of pancreatic cancers . A broad ranges of cancers are known to be a target for PI3K pathway, including pancreatic cancer. See p745, 1 st par. Conway explains: “ Collectively, this suggests that application of PI3K pathway inhibitors as a PDAC therapy may provide an opportunity for dual targeting of cancer cells and the deregulated cancer-associated stromal components. ” Id. PDAC patients with high PI3K have a poorer survival rate than those with low activation of PI3K. See p745, 2 nd par. Stockley teaches the compound of claim 2 with a diluent or carrier in prior art claim 1, shown below. The compound above can be used to treat conditions including cancer as an autotaxin inhibitor . See Abstract. Stockley also teaches the cells that may be treated include those of proliferative disorders of the pancreas . As noted above by Conway, 95% of pancreatic cancers are PDAC. Thus, treating PDAC would be immediately envisaged in view of the teachings to treat pancreatic cancers, generally. Routes of administration for treatment include oral administration. See col. 48, line 2. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven , 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) . It would have been prima facie obvious prior to the filing of the instant application to a person having ordinary skill in the art to arrive at the claimed methods in view of the cited prior art. One would be motivated to do so because: gemcitabine, nab-paclitaxel and anti-PD-1 therapies are known to be used to treat PDAC and pancreatic cancers when administered orally. Further, Gaillard teaches compounds that are PI3K inhibitors including the compound of claim 1 and Conway teaches that 95% of pancreatic cancers are PDAC and PI3K inhibitors are a therapeutic tool for treating the same. Thus, a POSA would have a reasonable expectation that the compound of claim 1 can treat cancers, pancreatic cancers, and PDAC. Moreover, Stockley teaches the compound recited in claim 2 as an autotaxin inhibitors that can treat proliferative disorders including pancreatic cancers. While Stockley does not teach PDAC explicitly, we know from Conway that 95% of pancreatic cancers are PDAC. Thus, it would not be reasonable to conclude with any statements to the contrary that an agent taught to treat pancreatic cancers would not be functional in treating 95% of pancreatic cancers that are PDAC. As such and in view of in re Kerkhoven, the use of gemcitabine, nab-paclitaxel, anti-PD-1 or anti-PD-L1 therapy, and administration of the claimed PI3K and autotaxin inhibitors would have a reasonable and predictable expectation of success in treating the claimed subject population based on their known and taught ability to treat the same subject population when administered orally with excipients as independent therapeutic agents. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-24 of copending Application No. 18/271,196 , in view of Wilkie et al. , (US2016/0128311), in view of Tomasini et al. , (US2020/0088732) (filed April 12, 208), in view of Conway et al. , “ Combating pancreatic cancer with PI3K pathway inhibitors in the era of personalized medicine ,” JRW et al. Gut 2019;68:742-758, in view of Stockley et al. , (U.S. Pat. No. 10,654,846). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 22-24 include the compound of Formula (I) claimed herein for treating any cancer, autoimmune, or inflammatory condition. While the claims of the ‘196 application include a salt form and dosages in claims 23 and 24, it would have been obvious to arrive at the claimed method and dosage in view of the known result-effective nature of the compound, which is taught to treat the claimed subject population. Claims of the ‘196 application are broader than the instant claims in that the instant claims other than claim 1 requires additional agents other than the compound of Formula (I). However, for the rationale set forth above, it would be obvious to arrive at the instant claims in view of the prior art and the claims of the ‘196 application and vice versa given the broader scope of the co-pending claims. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. As such, no claim is allowed. Conclusion THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JARED BARSKY/ Primary Examiner, Art Unit 1628